MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MDLR CNLTD TRIDRV DRVR
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that on the back table, during the case, the pin fell from the modular cannulated tri-drive driver.We took the drill from the anatomic set with no effect on the surgery.After the pin fell on the floor it was located and stored safely.The device is available for return.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H6: the broken tri-drive modular handle reported may have been due to numerous surgical uses and subsequent sterilization cycles, which resulted in the dowel pin disassociating from the assembly.However, this cannot be confirmed as although the device was sent to the uk head office, it was never received by the post market team for analysis.

• Brand Name: EQUINOXE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15115690
• Report Number: 1038671-2022-00852
• Device Sequence Number: 5849998
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MDLR CNLTD TRIDRV DRVR
• Device Catalogue Number: 315-25-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female